Baricitinib (5) – Olumiant®

Enthesitis-associated arthritis, ≥ 2 years

Characteristics

Start date 15.11.2023 – Marketing authorisation: 15.09.2023
Resolution 02.05.2024
INN Baricitinib
Brand name Olumiant®
Pharm. company Lilly Deutschland GmbH
G-BA Procedure ID D-1004
ATC code L04AF02 IMMUNOSUPPRESSANTS (L04A)
ICD-10 codes (AIS) M08.89Other juvenile arthritis, multiple sites
Alpha-ID codes (AIS) I120123Enthesitis-associated arthritis
Therapeutic area Musculoskeletal system diseases Juvenile idiopathic arthritis / Enthesitis-related arthritis
Reason for procedure New therapeutic indication
Specialty Bundling ACT change

Therapeutic indication of the resolution

Baricitinib is used for the treatment of active juvenile idiopathic arthritis in patients aged 2 years and older who have previously had an inadequate response or intolerance to one or more conventional synthetic or biologic DMARDs:

– Enthesitis-associated arthritis. Baricitinib can be used as monotherapy or in combination with methotrexate.
Subpopulation Indication Comparator
a) Children aged 2 to 5 years with active enthesitis-associated arthritis who have had an inadequate response or intolerance to one or more conventional synthetic or biologic DMARDs Adalimumab or etanercept
b) Children and adolescents aged 6 years and older with active enthesitis-associated arthritis who have had an inadequate response or intolerance to one or more conventional synthetic or biologic DMARDs Adalimumab or etanercept (≥ 12 years) or secukinumab

Studies and Results

No. of studies
(best subpopulation) 		0 (no data submitted)
Study design
(best subpopulation) 		no data submitted
Reason for dividing into subpopulations (G-BA) Age
ACT change 26.09.2023 – Neue Therapiestandards

  • Clinical trials
    • In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or a placebo.

a) Children aged 2 to 5 years with active enthesitis-related arthritis who have responded inadequately to, or are intolerant of, one or more conventional synthetic or biological DMARDs

  • For children aged 2 to 5 years with active enthesitis-associated arthritis who have responded inadequately to one or more conventional synthetic or biological DMARDs, or who have been unable to tolerate them, the additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of baricitinib compared with the appropriate comparator therapy.
  • In agreement with the pharmaceutical manufacturer, no suitable studies could be identified for a comparison of baricitinib with the appropriate comparator therapy.
  • In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or placebo.
  • In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.

b) Children and adolescents aged 6 years and over with active enthesitis-related arthritis who have responded inadequately to, or are intolerant of, one or more conventional synthetic or biological DMARDs

  • For children and adolescents aged 6 years and over with active enthesitis-associated arthritis who have responded inadequately to, or are intolerant of, one or more conventional synthetic or biological DMARDs, the additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of baricitinib compared with the appropriate comparator therapy.
  • In agreement with the pharmaceutical manufacturer, no suitable studies could be identified for a comparison of baricitinib with the appropriate comparator therapy.
  • In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or placebo.
  • In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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